The business-driven drug development problem and the public solution

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SUMMARY: THE BUSINESS-DRIVEN DRUG DEVELOPMENT PROBLEM AND THE PUBLIC SOLUTION Many amongst us cannot afford therapies that could improve our daily lives. Drugs are brought to shelves based on market dynamics that promise high financial rewards; decisions are largely insensitive to public need and social value. Our collective wellbeing is victim to the status quo: a profit-driven pharmaceutical-owned intellectual property system. Pharmaceutical companies set new drug prices that optimize their wallets; these prices in turn are protected from competition for years by intellectual property and patent laws. We must take action to construct a system that encourages innovation of highest social value while establishing access to therapies as a human right. To ensure our collective best interest, we should institute public ownership over publicly funded discoveries. In order to enable accessibility of therapies and sustain scientific innovation, we should supplant patents with grants and prizes.

ALL PATIENTS ARE VICTIMS: ONE IN FIVE AMERICANS DON’T FILL THEIR PRESCRIPTIONS One in ten split their pills in half or skip doses of therapies to save money. Three in ten report their condition worsens when they aren’t compliant with their therapy schedule. Roughly 9% of Americans are uninsured and face extreme cost barriers to accessing healthcare. But even the insured have coinsurances that often make high drug prices a harrowing financial burden. All patients seeking pharmacological assistance are victims to this system.

RESEARCH FOLLOWS THE MONEY, NOT SCIENTIFIC INNOVATION & SOCIAL WELFARE Across our private pharmaceutical titans, business rewards have the final say on research priorities. In 2018 Pfizer announced it was shutting down its research on Alzheimer’s and Parkinson’s disease, “abandoning costly but futile efforts” to find a cure to these two plagues of our modern age. A 2016 study showed that less than 6% of drug approvals are considered innovative (defined as tangible advances in therapy). The vast majority were small alterations to existing therapies, with no safety difference found between drug cohorts. Less than a third of drugs brought to market are first-in-class (the first drug offered in a disease space). AstraZeneca’s heartburn medicine Nexium is a poster child to this dystopian reality: it was awarded a patent for “a trivial and clinically insignificant modification of its existing heartburn drug” that was about to lose its patent and be sold as a generic. They were able to take in an extra 50 billion from this trick. Pharmaceutical companies structure their research priorities based on where the cash is: which patents are expiring soon? Which drugs have exhibited patterns of increasing sales?

WE LEGISLATED OUR DEMISE: WE ALLOW FOR PUBLICLY-FUNDED DISCOVERIES TO BE CAPITALIZED BY CORPORATIONS Most basic discovery and molecular research in the United States is publicly funded, with the primary contributor being the NIH (National Institutes of Health). Pharmaceutical and Venture Capital firms come in with big checks in the late-stages of development, testing and marketing. The few findings that aren’t directly derived from publicly funded experiments still rest on a large body of public research. In the 1980s through the Bayh Dole Act we permitted researchers to patent publicly funded discoveries and sell them to the pharmaceutical industry. This has led to the exploitation of public knowledge for the benefit of corporate interests. We pay for the discovery twice: through taxes and eye-gouging price tags once the cure hits the shelf.

THE RETURNS ON A PUBLIC INVESTMENT SHOULD BE PUBLIC DOMAIN We should ban the Bayh Dole Act and institute public ownership over publicly funded discoveries. This is not an idea without precedent in human intuition. When Jonas Salk, the primary scientist behind the development of the polio vaccine, was asked who owned the knowledge of that discovery, he responded: “The people ... There is no patent.” After the discovery of insulin at the University of Toronto, one of the collaborators filed for a patent and sold it back to the university for 1 dollar as an attempt to ensure nobody could profiteer over this public achievement. But we cannot rely on the benevolence of the human spirit. Patent monopolies should no longer be awarded. Instead, prize funds should be disbursed to groups and individuals who have been paramount in the development of innovative therapies. Bernie Sanders attempted to legislate this idea through the bill “Medical Innovation Prize Fund Act”, which would safeguard 0.55% of US GDP to fund health innovation prizes. This ensures strong financial rewards to groups who contribute to our collective wellbeing without making new therapeutics only accessible to the wealthy among us.

COUNTER ARGUMENTS: COULD THIS NEW SYSTEM STUNT INNOVATION? Some may be concerned that implementation of this proposal would result in a severe slow-down in scientific innovation. Through smaller financial incentives pharmaceutical companies might not have the capacity to fund costly clinical trials (which seek to assess medical safety and delineate the marginal therapeutic effect of a new drug). These are necessary to safely bring a new drug to market; thus, funding restrictions would severely delay a therapy getting from the wet lab to a patients’ hands. Furthermore, some might argue that improvements to delivery-methods (pill, intravenous, etc), packaging and distribution logistics also warrant meaningful financial rewards; It is a field with potential to improve patient safety, compliance and thereby outcomes.

OUR CURRENT SYSTEM DOES NOT INNOVATE, IT REPLICATES Our current drug approval system requests a pharmaceutical company to ensure patient safety and prove non-inferiority to any currently available solution. That is not the hallmark of a good investment in any other industry. We have to raise the bar and only financially encourage drug developments that improve on the status quo.

A NEW PRIZES & GRANTS VETTING SYSTEM IS NEEDED TO ENCOURAGE TRUE INNOVATION Public prizes will still allow pharmaceutical companies to be compensated for making improvements to delivery-methods, packaging and distribution frameworks. The new prize system, however, focuses its dollars on true therapeutic innovation. To receive an award one should show quantifiable improvements in clinical outcomes and/or quality of life. This is fodder for true innovations within the pharmaceutical space: experimenting with delivery-methods and packaging could improve patient compliance, which in turn may enhance drug efficacy. This proposed system disincentivizes spend on drug promotion and litigation (bolsters to our current high drug costs).

Having pharmaceutical companies own the measurement of their success (through clinical trial management) is a crucial part of the problem as well. Lexchin’s study showed “pharmaceutical companies have used techniques leading to bias in the content of clinical research at every stage in its production.” As owners of the evidence, pharmaceutical companies are incentivized to share information selectively and hide evidence that could hurt their financial gains.

Our new prize system proposes a third-party-vetted and publicly funded management of clinical trials. Trials should be run to assess superiority of an innovation (be it a new therapeutic, method of delivery, packaging system, etc). Most of the NIH’s grants are delivered to university groups and individuals who are performing research inside large academic institutions. Most of these organizations are also affiliated with large academic hospitals. We can similarly deliver grants to run clinical trials at the same institutions that are conducting molecular research. To conclude one’s prize application, there should be an unbiased cross validation of findings through an institution that has reported no conflict of interest. This prize awarding process requires multi-party agreement that the innovation under scrutiny improves patient outcomes and/or quality of life.

HURDLES TO IMPLEMENTATION Once we implement a public grant and prize system, it would still take years for our publicly owned drug knowledge to be turned into therapies within a patient’s reach. The clinical trial process will continue to be time-consuming in order to ensure public safety and assess the superiority of a new solution. We have thousands of active patents that are presently protecting high drug prices, making many therapies inaccessible to most. According to the American Constitution (28 USC section 1498), we already have the legislative power to nullify a patent (and thus ensure manufacturing rights to competitors) by paying the patent owner a royalty. Similarly, the Bayh-Dole Act as written allows for the government to step in and nullify a patent if acting on behalf of public interest. We can start today, accelerating public ownership by breaking current patents through prize awards. This starts to mitigate our systemic disease as we implement a broader cure: to make innovations to our wellbeing a public good that is accessible to all.